Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
18 years old to less ore equal than 65 with migraine defined according to the criteria of the headache Classification Committee (ICHD II) of the International Headache Society (HIS)
Migraine first onset before 50 years old
Occurrence of at least one episode every two months or up to 8 episodes per month during the previous 3 months, which must not exceed 14 days per month
Pain relief with the use of Over The Counter (OTC) medicines by at least 75% of episodes
Headache of at least moderate intensity (VAS greater than 30 mm), at least 75% of episodes
Absence of caffeine and black tea at least 2 hours before and one hour after drug administration
You may not be if
Use of acupuncture, homeopathy and/or phytotherapy
Use of Tryptanes in the last 30 hours, no steroidal anti-inflammatory drugs in the last 48 hours and analgesics in the last 15 hours
Use of analgesics drug products for more than 10 days per month, consecutive or not, for a period exceeding three months
Other types of headache that is not migraine, according to the International Classification of Headache Disorders (ICHD II)
Chronic and complicated migraine, according to ICHD II
Coexisting disease or significant medical conditions which in the investigators judgment interfere and/or prevent the individuals proper participation in the study
Treatment with methotrexate, glucocorticoids, anticoagulants and/or lithium
Hypersensibility to study medication (or any component of the formula), to acetyl salicylic, no steroidal anti-inflammatory drugs and/or any other analgesic or antipyretic
Nasal polyps, asthma and / or other allergic manifestations
Subjects with edema, diarrhea and/or vomiting, who are not eating or drinking fluids properly according to the investigators judgment or experiencing visual disorders
Use of antihypertensive medications and/or psychoactive in the last 6 months
History of anorexia, bulimia and/or mental disorders
History of tachycardia, arrhythmia, congestive heart failure, coronary artery disease and/or coagulopathy
History of thyroid disease and/or parathyroid disease, liver disease and/or gastrointestinal
History of dyspeptic disorder, including gastritis, peptic ulcer and/or gastrointestinal bleeding
Impaired renal function tests and/or history of renal disease, including kidney failure
Pregnant (or planning to become pregnant during the course of the study) or who are breast feeding
Woman in childbearing age, childbearing potential not protected by an effective contraceptive method of birth control. Status of pregnancy should be checked for pregnancy test serum or urine before exposure to the Investigational product.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Clareo Health | Ibuprofen Versus Ibuprofen Plus Caffeine in the Treatment of Migraine.
